It is looking likely that patients with Hodgkin's lymphoma will not be getting access to Takeda's Adcetris on the National Health Service in England, after the drug was turned down again by cost regulators despite new data and a drop in price.
Adcetria (brentuximab vedotin) is cleared in Europe to treat CD30-positive Hodgkin's lymphoma patients with: relapsed or refractory hodgkin's lymphoma after autologous stem cell transplant; a high risk of disease relapse or progression; and relapsed or refractory disease after two previous therapies when autologous stem cell transplant or multi-agent chemotherapy is not an option.
Back in August the National Institute for Health and Care Excellence published draft guidelines rejecting routine NHS use of the drug, which is currently available via the Cancer Drugs Fund in certain indications. This prompted submission of new evidence, new analyses and a patient access scheme by the firm, which the independent committee considered at the second appraisal committee meeting.
However, even taking into account the new data, the independent committee still concluded that there was substantial uncertainty in the clinical evidence for all three populations, and agreed that Adcetris could not be considered a cost effective use of NHS resources.
The decision again highlights the stark difference in medicines access in the UK's component nations, given that access to Adcetris was granted by the Scottish Medicines Consortium and the All Wales Medicine Strategy Group in 2014 and 2015, respectively. The Republic of Ireland has also approved access via its National Cancer Control Programme, while the drug is also available and reimbursed in all other major European countries.
Earlier this year, Jon Neal, business unit director, Oncology, Takeda UK, stressed that the drug "has been a game changer in the management of relapsed or refractory Hodgkin lymphoma and is the only licensed medicine in this setting", and that recently published five-year follow up data show that median overall survival for Adcetris was nearly 3.5 years, "longer than the historical survival data of less than three years quoted within the ACD".
Around 94 patients a year could be eligible for treatment with Adcetris if it were recommended for routine use for all three indications being appraised by NICE.